Inflammatory Bowel Disease Hospitalizations Are Similar for Patients Receiving Televisit-Delivered Outpatient Care and Those Receiving Traditional In-Person Care.

INTRODUCTION: The coronavirus disease 2019 pandemic resulted in widespread expansion of telehealth. However, there are concerns that telehealth-delivered outpatient care may limit opportunities for managing complications and preventing hospitalizations for patients with inflammatory bowel disease (IBD). We aimed to assess the association between outpatient IBD care delivered through televisit (video or phone) and IBD-related hospitalizations. METHODS: We conducted a case-control study of patients with IBD who had an IBD-related index hospitalization between April 2021 and July 2022 and received their care in the Veterans Health Administration. We matched these hospitalized patients to controls who were not hospitalized based on age, sex, race, Charlson comorbidity index, IBD type, IBD-related emergency department use, IBD-related hospitalizations, and outpatient gastroenterology visits in the preceding year. The variable of interest was the percentage of total clinic visits delivered through televisit in the year before the index hospitalization. We compared the risk of IBD-related hospitalization by exposure to televisit-delivered care using conditional logistic regression. RESULTS: We identified 534 patients with an IBD-related hospitalization and 534 matched controls without an IBD-related hospitalization during the study period. Patients with IBD with a higher percentage of televisit-delivered (vs in-person) outpatient care were less likely to be hospitalized during the study period (for every 10% increase in televisit use, odds ratio 0.97, 95% confidence interval 0.94-1.00; P = 0.03). DISCUSSION: Televisit-delivered outpatient IBD care is not associated with higher risk of IBD-related hospitalization. These findings may reassure clinicians that televisit-delivered outpatient care is appropriate for patients with complex chronic diseases such as IBD.

Morning light treatment for inflammatory bowel disease: a clinical trial.

BACKGROUND: Inflammatory bowel disease (IBD) affects over 3 million Americans and has a relapsing and remitting course with up to 30% of patients experiencing exacerbations each year despite the availability of immune targeted therapies. An urgent need exists to develop adjunctive treatment approaches to better manage IBD symptoms and disease activity. Circadian disruption is associated with increased disease activity and may be an important modifiable treatment target for IBD. Morning light treatment, which advances and stabilizes circadian timing, may have the potential to improve IBD symptoms and disease activity, but no studies have explored these potential therapeutic benefits in IBD. Therefore, in this study, we aim to test the effectiveness of morning light treatment for patients with IBD. METHODS: We will recruit sixty-eight individuals with biopsy-proven IBD and clinical symptoms and randomize them to 4-weeks of morning light treatment or 4-weeks of treatment as usual (TAU), with equivalent study contact. Patient-reported outcomes (IBD-related quality of life, mood, sleep), clinician-rated disease severity, and a biomarker of gastrointestinal inflammation (fecal calprotectin) will be assessed before and after treatment. Our primary objective will be to test the effect of morning light treatment versus TAU on IBD-related quality of life and our secondary objectives will be to test the effects on clinician-rated disease activity, depression, and sleep quality. We will also explore the effect of morning light treatment versus TAU on a biomarker of gastrointestinal inflammation (fecal calprotectin), and the potential moderating effects of steroid use, restless leg syndrome, and biological sex. DISCUSSION: Morning light treatment may be an acceptable, feasible, and effective adjunctive treatment for individuals with active IBD suffering from impaired health-related quality of life. TRIAL REGISTRATION: The study protocol was registered on ClinicalTrials.gov as NCT06094608 on October 23, 2023, before recruitment began on February 1, 2024.

Relationship between facility number of clinicians and prescribing intensity of psychotropic medications, opioids, and antibiotics in ambulatory practice.

BACKGROUND: Promoting appropriate pharmacotherapy requires understanding the factors that influence how clinicians prescribe medications. While prior work has focused on patient and clinician factors, features of the organizational setting have received less attention, though identifying sources of variation in prescribing may help identify opportunities to improve patient safety and outcomes. OBJECTIVE: To evaluate the relationship between the number of clinicians who prescribe medications in a facility and facility prescribing intensity of six individual medication classes by clinician specialty: benzodiazepines, antipsychotics, antiepileptics, and antidepressants by psychiatrists and antibiotics, opioids, antiepileptics, and antidepressants by primary care clinicians (PCPs). DESIGN: We used 2017 Veterans Health Administration (VHA) administrative data. SUBJECTS: We included patient-clinician dyads of older patients (> 55 years) with an outpatient encounter with a clinician in 2017. Patient-clinician data from 140 VHA facilities were included (n = 13,347,658). Analysis was repeated for years 2014 to 2016. MAIN MEASURES: For each medication, facility prescribing intensity measures were calculated as clinician prescribing intensity averaged over all clinicians at each facility. Clinician prescribing intensity measures included percentage of each clinician's patients prescribed the medication and mean number of days supply per patient among all patients of each clinician. KEY RESULTS: As the number of prescribing clinicians in a facility increased, the intensity of prescribing decreased. Every increase of 10 facility clinicians was associated with a significant decline in prescribing intensity for both specialties for different medication classes: for psychiatrists, declines ranged from 6 to 11%, and for PCPs, from 2 to 3%. The pattern of more clinicians less prescribing was significant across all years. CONCLUSION: Future work should explore the mechanisms that link the number of facility clinicians with prescribing intensity for benzodiazepines, antipsychotics, antiepileptics, antidepressants, antibiotics, and opioids. Facilities with fewer clinicians may need additional resources to avoid unwanted prescribing of potentially harmful or unnecessary medications.

Behavioral Health Provider Burnout and Mental Health Care in the Veterans Health Administration.

BACKGROUND: Although many studies assess predictors of provider burnout, few analyses provide high-quality, consistent evidence on the impact of provider burnout on patient outcomes exist, particularly among behavioral health providers (BHPs). OBJECTIVE: To assess the impact of burnout among psychiatrists, psychologists, and social workers on access-related quality measures in the Veterans Health Administration (VHA). DESIGN: This study used burnout in VA All Employee Survey (AES) and Mental Health Provider Survey (MHPS) data to predict metrics assessed by the Strategic Analytics for Improvement and Learning Value, Mental Health Domain (MH-SAIL), VHA's quality monitoring system. The study used prior year (2014-2018) facility-level burnout proportion among BHPs to predict subsequent year (2015-2019) facility-level MH-SAIL domain scores. Analyses used multiple regression models, adjusting for facility characteristics, including BHP staffing and productivity. PARTICIPANTS: Psychologists, psychiatrists, and social workers who responded to the AES and MHPS at 127 VHA facilities. MAIN MEASURES: Four compositive outcomes included two objective measures (population coverage, continuity of care), one subjective measure (experience of care), and one composite measure of the former three measures (mental health domain quality). KEY RESULTS: Adjusted analyses showed prior year burnout generally had no impact on population coverage, continuity of care, and patient experiences of care but had a negative impact on provider experiences of care consistently across 5 years (p < 0.001). Pooled across years, a 5% higher facility-level burnout in AES and MHPS had a 0.05 and 0.09 standard deviation worse facility experiences of care from the prior year, respectively. CONCLUSIONS: Burnout had a significant negative impact on provider-reported experiential outcome measures. This analysis showed that burnout had a negative effect on subjective but not on objective quality measures of Veteran access to care, which could inform future policies and interventions regarding provider burnout.

A 4-week morning light treatment with stable sleep timing for individuals with fibromyalgia: a randomized controlled trial.

OBJECTIVES: Fibromyalgia is characterized by chronic widespread pain, mood, and sleep disturbance. Pharmacological treatments have modest efficacy and are associated with negative side effects, and alternative approaches are needed. Morning bright light treatment may assist in the management of fibromyalgia as it can reduce depressive symptoms, improve sleep, and advance circadian timing. METHODS: Sixty people with fibromyalgia (58 women, mean age 41.8 ± 13.3 years) were enrolled in a study comparing 4 weeks of a 1-hour daily morning bright light treatment (active treatment) to a morning dim light treatment (comparison treatment). Both light treatments included behavioral procedures to stabilize sleep timing. The morning bright light treatment was expected to produce larger improvements in pain and function than the dim light treatment and larger improvements in potential mediators (mood, sleep, and circadian timing). RESULTS: Both the bright and dim light treatment groups achieved significant but similar levels of improvement in pain intensity, pain interference, physical function, depressive symptoms, and sleep disturbance. Overall, the sample on average displayed a clinically meaningful improvement in the Fibromyalgia Impact Questionnaire-Revised score (mean reduction of 11.2 points), comparable to that reported following physical exercise treatments. Minimal side effects were observed. CONCLUSIONS: Findings indicate that the effects of a morning bright light treatment did not exceed those of a comparison dim light treatment; yet the changes on average in both conditions revealed clinically meaningful improvements. Future research is warranted to identify what elements of this trial may have contributed to the observed effects.

Variation in Benzodiazepine and Antipsychotic Prescribing Among Hospice Agencies.

BACKGROUND: Benzodiazepines and antipsychotics are routinely prescribed for symptom management in hospice. There is minimal evidence to guide prescribing in this population, and little is known about how prescribing varies across hospice agencies. OBJECTIVE: Examine patient- and hospice agency-level characteristics associated with incident prescribing of benzodiazepines and antipsychotics in hospice. DESIGN: Retrospective cohort study of a 20% sample of Medicare beneficiaries newly enrolled in hospice. PARTICIPANTS: Medicare hospice beneficiaries ≥ 65 years old between 2014 and 2016, restricted to those without benzodiazepine (N = 169,688) or antipsychotic (N = 190,441) prescription fills in the 6 months before hospice enrollment. MAIN MEASURES: The primary outcome was incident (i.e., new) prescribing of a benzodiazepine or antipsychotic. A series of multilevel Cox regression models with random intercepts for hospice agency were fit to examine the association of incident benzodiazepine and antipsychotic prescribing with patient and hospice agency characteristics. KEY RESULTS: A total of 91,728 (54.1%) and 58,175 (30.5%) hospice beneficiaries were newly prescribed an incident benzodiazepine or antipsychotic. The prescribing rate of the hospice agency was the strongest predictor of incident prescribing: Compared to patients in bottom-quartile benzodiazepine-prescribing agencies, those in top-quartile agencies were 10.7 times more likely to be prescribed an incident benzodiazepine (adjusted hazard ratio [AHR] 10.7, 95% CI 10.1-11.3). For incident antipsychotic prescribing, patients in top-quartile agencies were 51.7 times more likely to receive an antipsychotic (AHR 51.7, 95% CI 44.3-60.4) compared to those in the bottom quartile. Results remained consistent accounting for comfort kit prescribing. CONCLUSIONS: The pattern of benzodiazepine or antipsychotic prescribing of a hospice agency strongly predicts whether a hospice enrollee is prescribed these medications, exceeding every other patient-level factor. While the appropriate level of prescribing in hospice is unclear, this variation may reflect a strong local prescribing culture across individual hospice agencies.

Sedentary patterns and cardiometabolic risk factors in Mexican children and adolescents: analysis of longitudinal data.

BACKGROUND: Sedentary behavior is a modifiable risk factor for cardiometabolic health; however, the assessment of total sedentary time may not capture youth's highly active and interrupted activity patterns. This study examined the associations between sedentary activity patterns and cardiometabolic risk factors among Mexican youth, who have a disproportionate burden of metabolic diseases, using a repeated measure design out of a longitudinal data. METHODS: 570 subjects in the Early Life Exposure in Mexico to ENvironmental Toxicants (ELEMENT) birth cohort, who were followed up to three-time points during adolescence, were included. Bout duration, and frequency and percentages of waking time spent in specific intensities of activity, were quantified using ActiGraph wGT3X-BT wrist accelerometers. Self-reported questionnaires were used to query the usual duration of different sedentary behaviors. Outcomes were fasting lipid profile, markers for glucose homeostasis, anthropometry, and blood pressure. Associations were modeled using linear mixed-effects models, and isotemporal substitution approach was additionally used to assess the effect of replacing objectively assessed sedentary activity with other activity intensities, adjusting for potential confounders. RESULTS: Each hour of self-reported screen-based time was positively associated with diastolic blood pressure (mm Hg) [ß = 0.30, 95% confidence interval (95% CI) = 0.10, 0.51], and an hour of other sedentary time was associated with log serum glucose (mg/dL) [ß = 0.01, 95% CI = 0.004, 0.017]. Substitution models showed that replacing 5% of sedentary time with moderate to vigorous physical activity (MVPA) was associated with lower waist circumference (cm) [ß = - 1.35, 95% CI = - 1.91, - 0.79] and log serum triglycerides (mg/dL) [ß = - 0.11, 95% CI = - 0.18, - 0.03]. Substituting one uninterrupted sedentary bout with light activity was associated with lower insulin (µIU/mL) [ß = - 0.06, 95% CI = - 0.10, - 0.02]. CONCLUSIONS: Sedentary time was associated with cardiometabolic risk factors in Mexican youth in a context-specific manner. Replacing sedentary time with higher intensities was associated with improvements in some cardiometabolic markers.

Prospective evaluation of an assessment tool for technical performance of duodenoscopes.

OBJECTIVE: While single-use and detachable-tip duodenoscopes have been recently developed to overcome risks of infection transmission, there are no reliable tools to objectively assess their technical performance. We evaluated the reliability and validity of a newly developed tool to assess the technical performance of reusable duodenoscopes. METHODS: An assessment tool was developed to measure duodenoscope performance based on three distinct criteria: maneuverability, mechanical/imaging characteristics and ability to perform requisite interventions. The assessment tool was tested prospectively on duodenoscopes used in endoscopic retrograde cholangiopancreatography (ERCP) procedures at nine academic medical centers over a 6-month period. The main outcome was reliability of the duodenoscope assessment tool, which was estimated using Cronbach's coefficient alpha (α). The secondary outcome was validity of the assessment tool. RESULTS: The assessment tool evaluated technical performance of reusable duodenoscopes in 1080 ERCP procedures. Indications were biliary in 92.8% and pancreatic in 7.2% procedures. The overall Cronbach's coefficient α for maneuverability was 0.81, assessment of mechanical/imaging characteristics was 0.92, and ability to perform requisite interventions was 0.87. On multiple linear regression analysis, prolonged procedure duration, older patient age and pancreatic interventions were significantly positively associated with higher (worse) scores. CONCLUSIONS: The newly developed assessment tool appears reliable and valid for evaluating the technical performance of duodenoscopes. Registration: ClinicalTrials.gov Identifier: NCT04004533.

Effect of Adding Telephone-Based Brief Coaching to an mHealth App (Stay Strong) for Promoting Physical Activity Among Veterans: Randomized Controlled Trial.

BACKGROUND: Though maintaining physical conditioning and a healthy weight are requirements of active military duty, many US veterans lose conditioning and rapidly gain weight after discharge from active duty service. Mobile health (mHealth) interventions using wearable devices are appealing to users and can be effective especially with personalized coaching support. We developed Stay Strong, a mobile app tailored to US veterans, to promote physical activity using a wrist-worn physical activity tracker, a Bluetooth-enabled scale, and an app-based dashboard. We tested whether adding personalized coaching components (Stay Strong+Coaching) would improve physical activity compared to Stay Strong alone. OBJECTIVE: The goal of this study is to compare 12-month outcomes from Stay Strong alone versus Stay Strong+Coaching. METHODS: Participants (n=357) were recruited from a national random sample of US veterans of recent wars and randomly assigned to the Stay Strong app alone (n=179) or Stay Strong+Coaching (n=178); both programs lasted 12 months. Personalized coaching components for Stay Strong+Coaching comprised of automated in-app motivational messages (3 per week), telephone-based human health coaching (up to 3 calls), and personalized weekly goal setting. All aspects of the enrollment process and program delivery were accomplished virtually for both groups, except for the telephone-based coaching. The primary outcome was change in physical activity at 12 months postbaseline, measured by average weekly Active Minutes, captured by the Fitbit Charge 2 device. Secondary outcomes included changes in step counts, weight, and patient activation. RESULTS: The average age of participants was 39.8 (SD 8.7) years, and 25.2% (90/357) were female. Active Minutes decreased from baseline to 12 months for both groups (P<.001) with no between-group differences at 6 months (P=.82) or 12 months (P=.98). However, at 12 months, many participants in both groups did not record Active Minutes, leading to missing data in 67.0% (120/179) for Stay Strong and 61.8% (110/178) for Stay Strong+Coaching. Average baseline weight for participants in Stay Strong and Stay Strong+Coaching was 214 lbs and 198 lbs, respectively, with no difference at baseline (P=.54) or at 6 months (P=.28) or 12 months (P=.18) postbaseline based on administrative weights, which had lower rates of missing data. Changes in the number of steps recorded and patient activation also did not differ by arm. CONCLUSIONS: Adding personalized health coaching comprised of in-app automated messages, up to 3 coaching calls, plus automated weekly personalized goals, did not improve levels of physical activity compared to using a smartphone app alone. Physical activity in both groups decreased over time. Sustaining long-term adherence and engagement in this mHealth intervention proved difficult; approximately two-thirds of the trial's 357 participants failed to sync their Fitbit device at 12 months and, thus, were lost to follow-up. TRIAL REGISTRATION: ClinicalTrials.gov NCT02360293; https://clinicaltrials.gov/ct2/show/NCT02360293. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/12526.

How Would Low-Income Communities Prioritize Medicaid Spending?

CONTEXT: Medicaid plays a critical role in low-income, minority, and medically underserved communities, particularly in states that have expanded Medicaid under the Affordable Care Act. Yet, the voices of underresourced communities are often unheard in decisions about how to allocate Medicaid's scarce resources, and traditional methods of public engagement are poorly suited to gathering such input. We argue that deliberative public engagement can be a useful tool for involving communities in setting Medicaid priorities. METHOD: We engaged 209 residents of low-income, medically underserved Michigan communities in discussions about Medicaid spending priorities using an exercise in informed deliberation: CHAT (CHoosing All Together). Participants learned about Medicaid, deliberated in small groups, and set priorities both individually and collectively. FINDINGS: Participants prioritized broad eligibility consistent with the ACA expansion, accepted some cost sharing, and prioritized spending in areas-including mental health-that are historically underfunded. Participants allocated less funding beyond benefit coverage, such as spending on healthy communities. Participants perceived the deliberative process as fair and informative, and they supported using it in the policy-making process. CONCLUSION: The choices of participants from low-income, medically underserved communities reflect a unique set of priorities and suggest that engaging low-income communities more deeply in Medicaid policy making might result in different prioritization decisions.

Discontinuation of Chronic Benzodiazepine Use Among Adults in the United States.

BACKGROUND: Guidelines recommend most benzodiazepine (BZD) treatment be short-term, though chronic BZD use is increasing. OBJECTIVE: Determine the rate of BZD discontinuation among chronic users and identify patient- and provider-level factors associated with discontinuation. DESIGN, SETTING, AND PARTICIPANTS: A retrospective cohort study using nationwide insurance claims data from 2014 to 2016 of US adults ≥ 18 years old with chronic BZD use (i.e., > 120 days) during the baseline year. MAIN OUTCOMES AND MEASURES: The primary outcome was BZD discontinuation among chronic users after 1 year of follow-up. A series of multilevel logistic regression models examined the association of BZD discontinuation with patient and provider characteristics. Covariates included patient sociodemographics, medical and psychiatric comorbidity, co-prescribed opioids and other psychotropics, and characteristics of the prescribed BZD. KEY RESULTS: Of 141,008 chronic BZD users, 13.4% discontinued use after 1 year. Females had lower odds of discontinuation (AOR 0.83, 99% CI 0.79-0.87), while African-American patients had higher odds (AOR 1.12, 99% CI 1.03-1.22). Those prescribed a high-potency BZD had lower odds of discontinuation (AOR 0.51, 99% CI 0.47-0.54), as did those prescribed an opioid (AOR 0.94, 99% CI 0.89-0.99). After adjusting for patient- and provider-level factors, differences between providers accounted for 5.8% of variation in BZD discontinuation (p < 0.001). The median odds ratio for provider was 1.54, an association with discontinuation larger than almost all patient-level clinical variables. CONCLUSIONS: A small minority of patients prescribed chronic BZD in a given year are no longer prescribed BZDs 1 year later. There is significant variation in the likelihood of discontinuation accounted for by non-clinical factors such as race, geography, and a patient's provider, which had a stronger association with the odds of discontinuation than almost every other patient-level variable. Provider-facing elements of interventions to reduce BZD prescribing may be critical.

Effectiveness of tobacco cessation pharmacotherapy in the Veterans Health Administration.

INTRODUCTION: In 2003, the Veterans Health Administration (VHA) implemented a directive that cessation pharmacotherapy be made available to all who use tobacco and are interested in quitting. Despite the efficacy of cessation pharmacotherapy shown in clinical trials, the generalisability of the results in real-world settings has been challenged. Hence, the specific aim of this study was to determine the effectiveness of cessation pharmacotherapies in the VHA. METHODS: This retrospective cohort study used VHA's electronic medical record data to compare quit rates among those who use tobacco and who did vs. did not receive any type of cessation pharmacotherapy. Included were 589 862 Veterans identified as current tobacco users during fiscal year 2011 who had not received cessation pharmacotherapy in the prior 12 months. Following a 6-month period to assess treatment, quit rates among those who were treated versus untreated were compared during the 7-18 months (12 months) post-treatment follow-up period. The estimated treatment effect was calculated from a logistic regression model adjusting for inverse probability of treatment weights (IPTWs) and covariates. Marginal probabilities of quitting were also obtained among those treated versus untreated. RESULTS: Adjusting for IPTWs and covariates, the odds of quitting were 24% higher among those treated versus untreated (OR=1.24, 95% CI 1.23 to 1.25, p<0.001). The marginal probabilities of quitting were 16.7% for the untreated versus 19.8% for the treated based on the weighted model. CONCLUSION: The increased quit rates among Veterans treated support the effectiveness and continuation of the VHA tobacco cessation pharmacotherapy policy.

Evaluating community deliberations about health research priorities.

CONTEXT: Engaging underrepresented communities in health research priority setting could make the scientific agenda more equitable and more responsive to their needs. OBJECTIVE: Evaluate democratic deliberations engaging minority and underserved communities in setting health research priorities. METHODS: Participants from underrepresented communities throughout Michigan (47 groups, n = 519) engaged in structured deliberations about health research priorities in professionally facilitated groups. We evaluated some aspects of the structure, process, and outcomes of deliberations, including representation, equality of participation, participants' views of deliberations, and the impact of group deliberations on individual participants' knowledge, attitudes, and points of view. Follow-up interviews elicited richer descriptions of these and also explored later effects on deliberators. RESULTS: Deliberators (age 18-88 years) overrepresented minority groups. Participation in discussions was well distributed. Deliberators improved their knowledge about disparities, but not about health research. Participants, on average, supported using their group's decision to inform decision makers and would trust a process like this to inform funding decisions. Views of deliberations were the strongest predictor of these outcomes. Follow-up interviews revealed deliberators were particularly struck by their experience hearing and understanding other points of view, sometimes surprised at the group's ability to reach agreement, and occasionally activated to volunteer or advocate. CONCLUSIONS: Deliberations using a structured group exercise to engage minority and underserved community members in setting health research priorities met some important criteria for a fair, credible process that could inform policy. Deliberations appeared to change some opinions, improved some knowledge, and were judged by participants worth using to inform policymakers.

Partner Plan Choices and Medicare Advantage Enrollment Decisions Among Older Adults.

This study examines the association of partner Medicare Advantage plan status over 1 year with beneficiary and plan characteristics.

Efficacy and Tolerability of Guanylate Cyclase-C Agonists for Irritable Bowel Syndrome with Constipation and Chronic Idiopathic Constipation: A Systematic Review and Meta-Analysis.

OBJECTIVES: Linaclotide and plecanatide are guanylate cyclase-C (GCC) agonists for the treatment of chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C). Our objective is to evaluate the efficacy and tolerability of GCC agonists based on data from multiple randomized controlled trials (RCTs). METHODS: We searched PubMED, EMBASE, Cochrane databases, clinicaltrials.gov, major conference abstracts, Food and Drug Administration (FDA) websites, and United States Securities and Exchange Commission filings of drug sponsors to identify RCTs of CIC or IBS-C patients. We assessed efficacy based on FDA-approved composite responder endpoints, diarrhea as an adverse event, and study withdrawal owing to diarrhea for each therapy. Trial results were pooled using DerSimonian and Laird random effects model of meta-analysis and exact logistic regression when appropriate with 95% confidence intervals. Meta-regression was performed to compare outcomes between therapies adjusting for placebo event rate. RESULTS: Eight linaclotide trials (five CIC; three IBS-C) and seven plecanatide trials (four CIC; three IBS-C) evaluating 10,369 patients met inclusion criteria. FDA publications documented that different definitions for diarrhea were used in linaclotide vs. plecanatide trials. Both drugs were efficacious in treating CIC (linaclotide 72 µg (Odds ratio (OR)=3.11, 95% CI 1.81-5.34); linaclotide 145 µg (OR=3.25, 2.15-4.91); plecanatide 3 mg (OR=1.99, 1.57-2.51)) and IBS-C (linaclotide 290 µg (OR=2.43, 1.48-3.98); plecanatide 3 mg (OR=1.87, 1.47-2.38); plecanatide 6 mg (OR=1.92, 1.48-2.48)). Diarrhea occurred in excess of placebo in treating CIC (linaclotide 72 µg (OR=3.07, 1.97-4.77); linaclotide 145 µg (OR=3.70, 2.69-5.10); plecanatide 3 mg (OR=3.86, 1.83-8.12)) and IBS-C (linaclotide 290 µg (OR=8.02, 5.20-12.37); plecanatide 3 mg (OR=5.55, 1.62-19.00); plecanatide 6 mg (OR=4.13, 1.57-10.83)). Based on meta-regression, there were no statistically significant differences between therapies in odds ratios for efficacy, diarrhea, or diarrhea-related study withdrawals. CONCLUSIONS: Both linaclotide and plecanatide demonstrate similar efficacy and tolerability in treating IBS-C and CIC. No differences in odds of diarrhea were seen between linaclotide and plecanatide.

Members of Minority and Underserved Communities Set Priorities for Health Research.

Policy Points Engaging and involving underrepresented communities when setting research priorities could make the scientific research agenda more equitable, more just, and more responsive to their needs and values. Groups and individuals from minority and underserved communities strongly prioritized child health and mental health research, often choosing to invest at the highest possible level. Groups consisting of predominantly Native American or Arab American participants invested in culture and beliefs research at the highest level, while many groups did not select it at all. The priority given to culture and beliefs research by these groups illustrates the importance of paying special attention to unique preferences, and not just commonly held views, when getting public input on spending priorities for research. CONTEXT: A major contributor to health disparities is the relative lack of resources-including resources for science-allocated to address the health problems of those with disproportionately greater needs. Engaging and involving underrepresented communities in setting research priorities could make the scientific research agenda more equitable, more just, and more responsive to their needs and values. We engaged minority and underserved communities in informed deliberations and report here their priorities for health research. METHODS: Academic-community partnerships adapted the simulation exercise CHAT for setting health research priorities. We had participants from minority and medically underserved communities (47 groups, n = 519) throughout Michigan deliberate about health research priorities, and we used surveys and CHAT software to collect the demographic characteristics and priorities selected by individuals and groups. FINDINGS: The participants ranged in age (18 to 88), included more women than men, and were overrepresented by minority groups. Nearly all the deliberating groups selected child health and mental health research (93.6% and 95.7%), and most invested at the highest level. Aging, access, promote health, healthy environment, and what causes disease were also prioritized by groups. Research on mental health and child health were high priorities for individuals both before and after group deliberations. Access was the only category more likely to be selected by individuals after group deliberation (77.0 vs 84.0%, OR = 1.63, p = .005), while improve research, health policy, and culture and beliefs were less likely to be selected after group deliberations (all, p < .001). However, the level of investment in many categories changed after the group deliberations. Participants identifying as Black/African American were less likely to prioritize mental health research, and those of Other race were more likely to prioritize culture and beliefs research. CONCLUSIONS: Minority and medically underserved communities overwhelmingly prioritized mental health and child health research in informed deliberations about spending priorities.

Assessing Responsiveness of Health Systems to Drug Safety Warnings.

OBJECTIVE: In 2011-2012 the U.S. Food and Drug Administration (FDA) issued safety announcements cautioning providers against prescribing high doses of citalopram given concerns for QT prolongation. The authors evaluated Veterans Affairs (VA) national trends in citalopram use and dose compared with alternative antidepressants after the FDA warnings. METHODS: Time series analyses estimated the effect of the FDA warnings on citalopram and other antidepressant across three periods: before the first FDA warning in August 2011, after the 2011 FDA warning until the second warning in March 2012, and after the 2012 FDA warning. In a National VA health system, adult VA outpatients prescribed citalopram or alternative antidepressants from February 2010 to September 2013 were studied. Outpatient use of high-dose citalopram (>40 or >20 mg daily in adults aged > 60 years) including the proportion of patients prescribed citalopram and difference between study periods. RESULTS: Between the first and second FDA warnings, among patients aged 18-60, high-dose citalopram use decreased by 2.0% per month (p < 0.001) and by 1.9% per month (p < 0.001) for older adults. After the second FDA warning in 2012, 30.7% of older patients remained on doses higher than the newly recommended dose of 20 mg. Reductions in overall use of citalopram were accompanied by significant increases in prescriptions of alternative antidepressants, with sertraline most widely prescribed. CONCLUSION: Although trends in high-dose citalopram use declined after the 2011-2012 FDA warnings, roughly one-third of older adults still remained on higher than recommended doses. Concomitant increases in sertraline and other antidepressant prescriptions suggest potential substitution of these medications for citalopram.

Trends and Patient Characteristics Associated with Tobacco Pharmacotherapy Dispensed in the Veterans Health Administration.

Introduction: There is evidence suggesting that certain subgroups of people who use tobacco do not receive tobacco pharmacology as consistently as others. Methods: This retrospective, cohort study examined the trend in the use of cessation pharmacotherapy from 2004 to 2013 using Veterans Health Administration (VHA) administrative data. Among Veterans who used tobacco in the fiscal year (FY) 2011 and had not received pharmacotherapy in the prior year, multivariable Cox regression was used to assess the independent associations between patient clinical and demographic characteristics and pharmacotherapy initiation in the 6-months follow-up period. Results: Smoking cessation pharmacotherapy in the VHA increased from 13.8% in 2004 to 25.6% in 2013. In 2011, Veterans (N = 838309) who were more likely to newly receive pharmacotherapy included those with psychiatric disorders (depression, bipolar disorder, non-alcohol substance use disorder, other anxiety, and post-traumatic stress disorder), chronic pulmonary disease, peripheral vascular disorders, and younger Veterans (adjusted rate ratios (ARRs) ranged from 1.03 to 1.92, all p < .001). Veterans less likely to receive pharmacotherapy were those with schizophrenia or other psychosis, males, Hispanics, and those with a medical condition (uncomplicated diabetes, uncomplicated hypertension, fluid and electrolyte disorders, cardiac arrhythmia, valvular disease, hypothyroidism, acquired immunodeficiency syndrome/human immunodeficiency virus, deficiency anemia, renal failure, paralysis, coagulopathy, metastatic cancer, and other neurological disorders) (ARRs ranged from 0.74 to 0.93, all p < .001). Conclusions: Although VHA cessation pharmacotherapy use nearly doubled from 13.8% in 2004 to 25.6% in 2013, reaching undertreated subgroups, especially those with medical comorbidities, may improve cessation outcomes. Implications: Despite evidence that demographics influence the use of pharmacotherapy in smoking cessation, there is limited and contradictory information regarding how psychiatric and chronic medical illnesses affect pharmacotherapy use. Administrative data were used to determine trends and patient characteristics of those receiving pharmacotherapy to aid in smoking cessation in the Veterans Health Administration. From 2004 to 2013, pharmacotherapy use increased from 13.8% to 25.6% of current smokers. Factors associated with increased pharmacotherapy initiation were psychiatric disorders, chronic pulmonary disease, peripheral vascular disorders, and younger age. Veterans with schizophrenia or other psychosis, males, Hispanics, and most medical conditions were less likely to receive pharmacotherapy.

Real-Time Characterization of Diminutive Colorectal Polyp Histology Using Narrow-Band Imaging: Implications for the Resect and Discard Strategy.

BACKGROUND & AIMS: Narrow-band imaging (NBI) allows real-time histologic classification of colorectal polyps. We investigated whether endoscopists without prior training in NBI can achieve the following thresholds recommended by the American Society for Gastrointestinal Endoscopy: for diminutive colorectal polyps characterized with high confidence, a ≥90% negative predictive value for adenomas in the rectosigmoid and a ≥90% agreement in surveillance intervals. METHODS: Twenty-six endoscopists from 2 tertiary care centers underwent standardized training in NBI interpretation. Endoscopists made real-time predictions of diminutive colorectal polyp histology and surveillance interval predictions based on NBI. Their performance was evaluated by comparing predicted with actual findings from histologic analysis. Multilevel logistic regression was used to assess predictors of performance. Cumulative summation analysis was used to characterize learning curves. RESULTS: The endoscopists performed 1451 colonoscopies and made 3012 diminutive polyp predictions (74.3% high confidence) using NBI. They made 898 immediate post-procedure surveillance interval predictions. An additional 505 surveillance intervals were determined with histology input. The overall negative predictive value for high-confidence characterizations in the rectosigmoid was 94.7% (95% confidence interval: 92.6%-96.8%) and the surveillance interval agreement was 91.2% (95% confidence interval: 89.7%-92.7%). Overall, 97.0% of surveillance interval predictions would have brought patients back on time or early. High-confidence characterization was the strongest predictor of accuracy (odds ratio = 3.42; 95% confidence interval: 2.72-4.29; P < .001). Performance improved over time, however, according to cumulative summation analysis, only 7 participants (26.9%) identified adenomas with sufficient sensitivity such that further auditing is not required. CONCLUSIONS: With standardized training, gastroenterologists without prior expertise in NBI were able to meet the negative predictive value and surveillance interval thresholds set forth by the American Society for Gastrointestinal Endoscopy. The majority of disagreement in surveillance interval brought patients back early. Performance improves with time, but most endoscopists will require ongoing auditing of performance. ClinicalTrials.gov ID NCT02441998.

Impact of Bilateral Prophylactic Mastectomy and Immediate Reconstruction on Health-Related Quality of Life in Women at High Risk for Breast Carcinoma: Results of the Mastectomy Reconstruction Outcomes Consortium Study.

BACKGROUND: Although bilateral prophylactic mastectomy (BPM) can reduce the risk of breast cancer, the decision to proceed surgically can have significant consequences and requires careful deliberation. To facilitate decision making for women at high risk for breast carcinoma, the risks and benefits of BPM should be well-elucidated. We sought to determine the effects of BPM and immediate reconstruction on health-related quality-of-life outcomes among a multisite cohort of women at high risk for breast carcinoma. METHODS: Patient-reported outcome data were prospectively collected as part of the Mastectomy Reconstruction Outcomes Consortium Study, and data on a subgroup of 204 high-risk women who elected to have BPM and immediate reconstruction were evaluated. Baseline scores were compared with scores at 1 or 2 years after reconstruction. RESULTS: Satisfaction with breasts and psychosocial well-being were significantly higher at both 1 and 2 years (p < 0.01); however, anxiety was significantly lower at 1 or 2 years (p < 0.01) and physical well-being of the chest and upper body was significantly worse at 1 year (p < 0.01). CONCLUSION: Our results highlight the impact of BPM and immediate reconstruction on health-related quality-of-life outcomes in this setting. BPM and reconstruction can result in significant, positive, lasting changes in a woman's satisfaction with her breasts, as well as her psychosocial well-being. Furthermore, presurgery anxiety was significantly reduced by 1 year post-reconstruction and remained reduced at 2 years. With this knowledge, women at high risk for breast carcinoma, and their providers, will be better equipped to make the best individualized treatment decisions.